Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Malignancies
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 13
- 主要终点
- Adverse events of each patient.
研究概览
简要总结
This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies.
详细描述
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR T-cells. Patients will receive the CD19CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with high risk relapsed CD19+ malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
- •Life expectancy>3 months.
- •Gender unlimited, age from 18 years to 70 years.
- •CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
- •Patients who have failed at least one line of a standard treatment.
- •No serious mental disorder.
- •Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
- •No other serious diseases(autoimmune disease, immunodeficiency etc.).
- •No other tumors.
- •Patients volunteer to participate in the research.
- •Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial.
排除标准
- •Patients are allergic to cytokines.
- •Central nervous system leukemia within 28 days.
- •Uncontrolled active infection.
- •Acute or chronic GVHD.
- •Treated with T cell inhibitor.
- •Pregnancy and nursing females.
- •HIV/HBV/HCV Infection.
- •Other situations we think improper for the research.
结局指标
主要结局
Adverse events of each patient.
时间窗: 3 years
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
次要结局
- Antitumor Effects(Every 3 months post treatment up to 24 months)
- Survival time of Anti-CD19 CAR T cells in vivo.(3 years)
- Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.(4 weeks)